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Идёт набор NCT04494945

Identifying and Caring for Individuals With Inherited Cancer Syndrome

Без фазы С лечением BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome Breast Ductal Carcinoma In Situ Hematopoietic and Lymphoid System Neoplasm Hereditary Neoplastic Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Biospecimen Collection, Genetic Counseling, Genetic Testing, Survey Administration.
Кому может быть актуально
Состояния в реестре: BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome, Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphoid System Neoplasm, Hereditary Neoplastic Syndrome. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Approaches to Identify and Care for Individuals With Inherited Cancer Syndromes

Обзор

This trial examines approaches to identify and care for individuals with inherited cancer syndrome. The purpose of this study is to offer no cost genetic testing to the general public. Researchers hope to learn the value of providing broad, public-wide testing for high risk cancer types (like hereditary breast and ovarian cancer or Lynch syndromes) instead of only testing people whose families are known to be high risk.

Подробное описание

PRIMARY OBJECTIVE:

I. Evaluate the effectiveness and sustainability of heritable cancer syndrome testing in two proposed screening populations compared to current guidelines.

SECONDARY OBJECTIVES:

I. Measure adherence to current guidelines for screening and prophylactic intervention of Cohorts B and C compared to Cohort A to show non-inferiority.

II. Measure the efficiency of cascade testing (defined as the ratio of family members screened over total possible) for Cohorts B and C compared to Cohort A to show non-inferiority.

III. Determine the costs and effectiveness, specifically quality adjusted life years (QALYs) associated with genetic screening models based on Cohorts B and C to estimate incremental cost-effectiveness ratio (ICER) and show that the costs per QALY are below the acceptable cost effectiveness threshold.

OUTLINE:

Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling. Patients also complete a survey about cancer prevention, screening, and treatment.

Вмешательства

  • Процедура Biospecimen Collection
    Undergo collection of saliva sample
  • Другое Genetic Counseling
    Receive genetic counseling if testing results are positive
  • Другое Genetic Testing
    Undergo genetic testing
  • Другое Survey Administration
    Complete a survey

Первичные конечные точки

  • Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations [Срок оценки: Up to 5 years]
  • Adherence to standard of care for hereditary breast and ovarian cancer (HBOC) and Lynch syndromes [Срок оценки: Up to 5 years]
  • Merged risk reduction strategies of bilateral salpingo-oophorectomy (BSO) or bilateral mastectomy and imaging [Срок оценки: Up to 5 years]
  • Cascade screening rate among Lynch or HBOC positive carriers [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

  • ALL COHORTS: 18 years of age or older
  • Retrospective COHORT A: Per HIPAA waiver, Retrospective Cohort A will not actively consent
  • Retrospective COHORT A: Patients may or may not be diagnosed with cancer
  • Retrospective COHORT A: Patients have received genetic counseling in the past 5 years
  • Retrospective COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and/or Lynch syndrome
  • COHORT A: Per Health Insurance Portability and Accountability Act (HIPAA) waiver, Cohort A returns survey as consent
  • COHORT A: Patients may or may not be diagnosed with cancer
  • COHORT A: Patients have received genetic counseling in the past 1 - 2 years
  • COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and/or Lynch syndrome
  • COHORT A: INCLUSIVE of no contact list to exclude from Cohort B
  • COHORT B: Creation of secure Healthy Oregon Project (HOP) app account
  • COHORT B: Consent to this project, either hard or electronic signature
  • COHORT B: Consent to the HOP repository, either hard or electronic signature
  • COHORT B: Choosing to submit a deoxyribonucleic acid (DNA) sample
  • COHORT B: Patients diagnosed with any National Cancer Institute (NCI)-reportable cancers, including ductal carcinoma in situ (DCIS) and/or in situ breast cancer
  • COHORT B: Must have had an encounter within past twelve months
  • COHORT B: Exclude Cohort A
  • COHORT C: Creation of secure Hop app account
  • COHORT C: Consent to this project, either hard or electronic signature
  • COHORT C: Consent to the HOP repository, either hard or electronic signature
  • COHORT C: Choosing to submit a DNA sample

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

США · 2 центра
  • Providence Portland Medical Center — Portland
  • OHSU Knight Cancer Institute — Portland

Идентификаторы

NCT: NCT04494945 · STUDY00020629 · NCI-2020-04627 · STUDY00020629 · U01CA232819

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗